WO2016046294A1 - Système de préparation pour nourrissons avec niveaux adaptatifs d'oligosaccharides de lait humain - Google Patents

Système de préparation pour nourrissons avec niveaux adaptatifs d'oligosaccharides de lait humain Download PDF

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Publication number
WO2016046294A1
WO2016046294A1 PCT/EP2015/071930 EP2015071930W WO2016046294A1 WO 2016046294 A1 WO2016046294 A1 WO 2016046294A1 EP 2015071930 W EP2015071930 W EP 2015071930W WO 2016046294 A1 WO2016046294 A1 WO 2016046294A1
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WIPO (PCT)
Prior art keywords
nutritional composition
age
composition
nutritional
amount
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PCT/EP2015/071930
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English (en)
Inventor
Frederic Destaillats
Carlos Antonio DE CASTRO
Norbert Sprenger
Sagar THAKKAR
Sean Christopher Austin
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Nestec S.A.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=54238414&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2016046294(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to CN201580051698.2A priority Critical patent/CN106714583A/zh
Priority to ES15771909T priority patent/ES2725464T3/es
Priority to US15/514,145 priority patent/US10820616B2/en
Priority to BR112017003920A priority patent/BR112017003920A2/pt
Priority to AU2015323762A priority patent/AU2015323762A1/en
Application filed by Nestec S.A. filed Critical Nestec S.A.
Priority to EP15771909.7A priority patent/EP3197295B1/fr
Priority to MX2017003441A priority patent/MX2017003441A/es
Priority to RU2017113997A priority patent/RU2761533C2/ru
Publication of WO2016046294A1 publication Critical patent/WO2016046294A1/fr
Priority to PH12017500174A priority patent/PH12017500174A1/en
Priority to AU2020201932A priority patent/AU2020201932A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/30—Dietetic or nutritional methods, e.g. for losing weight
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates to an age-tailored nutritional composition system comprising human milk oligosaccharides (HMOs), wherein the amount of HMOs present in each nutritional composition is selected according to the age of the infants.
  • the invention further relates to the use of said age-tailored nutritional composition system for providing a health benefit to infants.
  • the invention also relates to an infant nutrition kit comprising a set of age-tailored nutritional compositions and to an infant nutrition regimen comprising feeding said age-tailored nutritional compositions. Finally, the invention relates to a method for manufacturing a set of age-tailored nutritional compositions for infants.
  • Breast milk is the most nutritionally sound food for babies. It consists of nutrients, such as proteins, lipids, carbohydrates, minerals, vitamins, and trace elements that babies need to grow healthy. It also contains immune-related components such as IgA, leukocytes, oligosaccharides, lysozyme, lactoferrin, interferon- ⁇ , nucleotides, cytokines, and others. Several of these compounds offer passive protection in the gastrointestinal tract and to some extent in the upper respiratory tract, preventing adherence of pathogens to the mucosa and thereby protecting the breast-fed infant against invasive infections. Human milk also contains essential fatty acids, enzymes, hormones, growth factors, polyamines, and other biologically active compounds, which may play an important role in the health benefits associated with breastfeeding.
  • nutrients such as proteins, lipids, carbohydrates, minerals, vitamins, and trace elements that babies need to grow healthy. It also contains immune-related components such as IgA, leukocytes, oligosaccharides, lysozyme
  • HMOs human milk oligosaccharides
  • WO2012156273 discloses a method for the manufacture of an infant formula or an infant nutritional product comprising mixture of human milk oligosaccharides. Based on dry mass, HMOs are the third largest milk compound group present in human milk. They play a vital role in the early development of young children.
  • HMOs may serve as prebiotics in the form of indigestible carbohydrates that are selectively fermented by desirable gut microbiota.
  • the known effects of HMOs in the maturation of the immune system and their prognostic use as immunomodulators underline their importance for the healthy development of infants in their first year of life.
  • the invention in a first aspect, relates to an age-tailored nutritional composition system comprising at least one nutritional composition A for infants from 0 up to 1 month of age and at least one nutritional composition B for infants above 1 month and up to 2 months of age, wherein the nutritional compositions A and B comprise human milk oligosaccharides (HMOs), and wherein said nutritional compositions A and B differ from each other in the amount of HMOs present therein.
  • HMOs human milk oligosaccharides
  • the age-tailored nutritional composition system further comprises at least one nutritional composition C for infants above 2 months and up to 4 months of age, preferably wherein the nutritional compositions C comprise human milk oligosaccharides (HMOs), and more preferably wherein nutritional compositions A, B and C differ from each other in the amount of HMOs present therein.
  • the invention relates to the age-tailored nutritional composition system according to the first aspect, wherein the amounts of HMOs present in each nutritional composition are selected according to the age of the infants.
  • the at least one nutritional composition C comprises HMOs in an amount of from 500 to 2500 mg/L, preferably from 1500 to 2000 mg/L, more preferably from 1863 to 1902 mg/L, and most preferably in an amount of 1883 mg/L of composition.
  • the HMOs are selected from “sialylated oligosaccharides”, “fucosylated oligosaccharides”, “N-acetylated oligosaccharides” or any mixtures thereof.
  • each one of 2'Fucosyllactose (2'FL, 2FL or 2-FL), 3'Sialyllactose (3'SL, 3SL, or 3-SL), 6'Sialyllactose (6'SL, 6SL or 6-SL), Lacto-N- neotetraose (LNnT) and Lacto-N-tetraose (LNT) is present in a nutritional
  • composition of the age-tailored nutritional composition system of the first aspect in an amount of from 50 to 5000 mg/L of composition, or in an amount of from 70 to 4000 mg/L, from 80 to 3000 mg/L, from 95 to 2000 mg/L, from 100 to 1700 mg/L, from 125 to 1400mg/L, from 130 to 1300 mg/L, from 150 to 920 mg/L, from 190 to 900 mg/L, from 200 to 800 mg/L, from 205 to 650 mg/L, from 231 to 600 mg/L, from 239 to 550 mg/L, from 240 to 540 mg/L, from 250 to 500 mg/L, from 255 to 400 mg/L, from 280 to 350 mg/L, or 300 mg/L of composition.
  • 2'Fucosyllactose is present in a nutritional composition in an amount of from 500 to 5000 mg/L, preferably from 800 to 4000 mg/L, from 900 to 2000 mg/L, from 920 to 1700 mg/L, from 949 to 1520 mg/L, from 980 to 1500 mg/L, from 1000 to 1484 mg/L, from 1000 to 1450 mg/L, from 1200 to 1300 mg/L, or from 1206 to 1210 mg/L of composition.
  • 3'Sialyllactose is present in a nutritional composition in an amount of from 150 to 280 mg/L, preferably from 190 to 250 mg/L, from 200 to 240 mg/L, from 205 to 231 mg/L, from 210 to 230 mg/L, from 21 1 to 225 mg/L, or from 215 to 220 mg/L of composition.
  • 6'Sialyllactose is present in a nutritional composition in an amount of from 80 to 650 mg/L, preferably from 100 to 600 mg/L, from 125 to 550 mg/L, from 130 to 540 mg/L, from 135 to 530 mg/L, from 150 to 500 mg/L, from 180 to 450 mg/L, from 200 to 350 mg/L, from 250 to 300 mg/L, from 270 to 280 mg/L, or from 272 to 275 mg/L of composition.
  • Lacto-N-neotetraose is present in a nutritional composition in an amount of from 50 to 350 mg/L, preferably from 70 to 280 mg/L, from 80 to 255 mg/L, from 95 to 239 mg/L, from 100 to 220 mg/L, from 1 10 to 200 mg/L, from 120 to 180 mg/L, from 130 to 165 mg/L, or from 148 to 150 mg/L composition.
  • 2'Fucosyllactose is present in the at least one nutritional composition A in an amount of from 500 to 5000 mg/L, preferably from 900 to 4000 mg/L, more preferably from 1000 to 2000 mg/L, even more preferably from 1300 to 1700 mg/L, even more preferably from 1450 to 1520 mg/L, most preferably 1484 mg/L of composition.
  • 2'Fucosyllactose is present in the at least one nutritional composition C in an amount of from 800 to 1200 mg/L, preferably from 900 to 1000 mg/L, more preferably from 920 to 980 mg/L, most preferably 949 mg/L of
  • 3'Sialyllactose is present in the at least one nutritional composition A in an amount of from 200 to 280 mg/L, preferably from 210 to 250 mg/L, more preferably from 225 to 240 mg/L, most preferably 231 mg/L of
  • 3'Sialyllactose is present in the at least one nutritional composition C in an amount of from 150 to 250 mg/L preferably from 180 to 220 mg/L, more preferably from 200 to 210 mg/L, most preferably 205 mg/L of composition.
  • Lacto-N-neotetraose is present in the at least one nutritional composition A in an amount of from 150 to 350 mg/L, preferably from 200 to 280 mg/L, more preferably from 220 to 255 mg/L, most preferably 239 mg/L of composition.
  • Lacto-N-tetraose is present in the at least one nutritional composition A in an amount of from 600 to 4000 mg/L, preferably from 700 to 3000 mg/L, more preferably from 800 to 1400 mg/L, even more preferably from 1000 to 1300 mg/L, even more preferably from 1060 to 1215 mg/L, most preferably 1 138 mg/L of composition.
  • Lacto-N-tetraose is present in the at least one nutritional composition B in an amount of from 500 to 1000 mg/L, preferably from 600 to 850 mg/L, more preferably from 730 to 750 mg/L, most preferably 741 mg/L of
  • Lacto-N-tetraose is present in the at least one nutritional composition C in an amount of from 300 to 700 mg/L, preferably from 400 to 600 mg/L, more preferably from 490 to 515 mg/L, most preferably 504 mg/L of
  • the invention relates to the use of the age-tailored nutritional composition system according to the first aspect for feeding an infant.
  • the invention in a sixth aspect, relates to a method for the manufacture of a set of nutritional compositions for infants comprising the steps of preparing at least one nutritional composition A for infants from 0 up to 1 month of age and at least one nutritional composition B for infants above 1 month and up to 2 months of age, wherein preparation of each composition comprises blending together at least a protein source, a carbohydrate source, and a fat source; selecting for each of the at least one nutritional composition A and the at least one nutritional composition B an amount of HMOs according to the age of the infants, and incorporating said selected amount of HMOs into the corresponding nutritional composition, such that said nutritional compositions A and B differ from each other in the amount of HMOs present therein.
  • the method according to the sixth aspect further comprises the steps of preparing at least one nutritional composition C for infants above 2 months and up to 4 months of age, selecting for said nutritional composition C an amount of HMOs according to the age of the infants, and incorporating said selected amount of HMOs into at least one nutritional composition C, preferably such that the nutritional compositions A and B and C differ from each other in the amount of HMOs present therein.
  • the HMOs are selected for a nutritional composition in a total amount of from 500 to 10000 mg/L, preferably from 1000 to 8000 mg/L, from 1500 to 5000 mg/L or from 1800 to 4000 mg/L of composition.
  • the HMOs are selected for a nutritional composition in a total amount of from 1863 to 3673 mg/L, from 1883 to 3632 mg/L, from 1902 to 3590 mg/L, from 2000 to 3500mg/L, from 2500 to 3000 mg/L, from 2558 to 2602 mg/L or in an amount of 2580mg/L of composition.
  • the amount of HMOs selected for the at least one nutritional composition A exceeds the amount of HMOs selected for the at least one nutritional composition B
  • the amount of HMOs selected for the at least one nutritional composition B exceeds the amount of HMOs selected for the at least one nutritional composition C.
  • the method according to the sixth aspect further comprises the step of preparing at least one nutritional composition D for infants above 4 months of age and, optionally, any further nutritional compositions E, F,G, H, I, etc., selecting for said at least one nutritional composition D and, optionally, for each of said further nutritional compositions (E, F, etc.) an amount of HMOs according to the age of the infants, and incorporating said selected amount of HMOs into the at least one nutritional composition D and, optionally, into the further nutritional compositions (E, F, etc.), respectively.
  • an amount of HMOs is selected for the at least one nutritional composition D and, optionally, for each of said further nutritional compositions (E, F, etc.), such that the nutritional compositions A, B, C, D and, optionally, any further nutritional compositions E, F, etc. differ from each other in the amount of HMOs present therein. More preferably, the amount of HMOs selected for each one of nutritional compositions A, B and C exceeds the amount of HMOs selected for the at least one nutritional composition D and, optionally, for any further nutritional compositions E, F, etc.
  • HMOs selected for the at least one nutritional composition D exceeds the amount of HMOs selected for the at least one nutritional composition E
  • the amount of HMOs selected for the at least one nutritional composition E exceeds the amount of HMOs selected for the at least one nutritional composition F, etc.
  • HMOs are selected for the at least one nutritional composition A in a total amount of from 1000 to 10000 mg/L, preferably from 1500 to 8000 mg/L, more preferably from 2000 to 5000 mg/L, even more preferably from 3000 to 4000 mg/L, even more preferably from 3590 to 3673 mg/L, and most preferably in an amount of 3632 mg/L of composition.
  • HMOs are selected for the at least one nutritional composition B in an amount of from 1500 to 3500 mg/L, preferably from 2000 to 3000 mg/L, more preferably from 2558 to 2602 mg/L, and most preferably in an amount of 2580 mg/L of composition.
  • HMOs are selected for the at least one nutritional composition C in an amount of from 500 to 2500 mg/L, preferably from 1500 to 2000 mg/L, more preferably from 1863 to 1902 mg/L, and most preferably in an amount of 1883 mg/L of composition.
  • the step of preparing at least one nutritional composition A for infants from 0 up to 1 month of age comprises preparing two nutritional compositions A.
  • these two nutritional compositions A are a first nutritional composition A1 for infants from 0 up to 3-7 days of age and a second nutritional composition A2 for the rest of the time period up to 1 month of age.
  • the two nutritional compositions A may be a first nutritional composition A1 for infants from 0 up to 7 days of age, and a second nutritional composition A2 for infants from 8 days up to 1 month of age, or a first nutritional composition A1 for infants from 0 up to 6 days of age and a second nutritional composition A2 for infants from 7 days up to 1 month of age, or a first nutritional composition A1 for infants from 0 up to 5 days of age and a second nutritional composition A2 for infants from 6 days up to 1 month of age, or a first nutritional composition A1 for infants from 0 up to 4 days of age and a second nutritional composition A2 for infants from 5 days up to 1 month of age, or a first nutritional composition A1 for infants from 0 up to 3 days of age and a second nutritional composition A2 for infants from 4 days up to 1 month of age.
  • an amount of HMOs is selected according to the age of the infants, more preferably wherein said amount of HMOs is selected such that nutritional compositions A1 and A2 differ from each other in the amount of HMOs present therein. It is particularly preferred that for each of nutritional compositions A1 and A2 the amount of HMOs is selected such that the amount of HMOs selected for nutritional composition A1 exceeds the amount of HMOs selected for nutritional composition A2.
  • the HMOs may be selected in an amount of from 5000 to 10000 mg/L, and preferably from 5000 to 8000 mg/L of composition.
  • the HMOs be selected in an amount of from 1000 to 5000 mg/L, preferably from 1500 to 4000 mg/L, more preferably from 2000 to 3673 mg/L, even more preferably from 3000 to 3632mg/L, and most preferably of 3590 mg/L of composition.
  • the step of preparing at least one nutritional composition A for infants from 0 up to 1 month of age comprises preparing three nutritional compositions A.
  • these three nutritional compositions A are a first nutritional composition A1 for infants from 0 up to 5 days, a second nutritional composition A2 for infants from 6 up to 15 days and a third nutritional composition A3 for infants for the rest of the time period up to 1 month of age (i.e. from 16 days up to 30 or 31 days).
  • Said first nutritional composition A1 may preferably comprise HMOs in an amount of from 5000 to 10000 mg/L, and more preferably from 5000 to 8000 mg/L of composition.
  • the second nutritional composition A2 may preferably comprise HMOs in an amount of from 1000 to 5000 mg/L, preferably from 1500 to 4000 mg/L, more preferably from 2000 to 3673 mg/L, even more preferably from 3000 to 3632mg/L, and most preferably of 3590 mg/L of composition.
  • the third nutritional composition A3 may preferably comprise HMOs in an amount of from 500 to 4500 mg/L, preferably from 1000 to 4000 mg/L, more preferably from 2000 to 3500 mg/L, more preferably from 3000 to 3500 mg/L of the composition.
  • the selected amount of HMOs is incorporated into the corresponding nutritional composition during preparation of said composition, preferably by blending the HMOs together with the protein source, the carbohydrate source, and the fat source.
  • the selected amount of HMOs is incorporated into the corresponding nutritional composition by preparing said composition in a first step and adding the HMOs to the ready prepared composition in a second step.
  • the invention relates to the method according to the sixth aspect, wherein the HMOs are selected from HMOs which are naturally present in human breast milk.
  • HMOs are selected from “sialylated
  • the HMOs are selected from
  • 6'Sialyllactose (6'SL, 6SL or 6-SL), Lacto-N-neotetraose (LNnT), Lacto-N-tetraose (LNT), or any combination thereof.
  • each one of 2'Fucosyllactose (2'FL, 2FL or 2-FL), 3'Sialyllactose (3'SL, 3SL, or 3-SL), 6'Sialyllactose (6'SL, 6SL or 6-SL), Lacto-N- neotetraose (LNnT) and Lacto-N-tetraose (LNT) is selected for a nutritional composition of the age-tailored nutritional composition system of the sixth aspect in an amount of from 50 to 5000 mg/L of composition, and more preferably in an amount of from 70 to 4000 mg/L, from 80 to 3000 mg/L, from 95 to 2000 mg/L, from 100 to 1700 mg/L, from 125 to 1400mg/L, from 130 to 1300 mg/L, from 150 to 920 mg/L, from 190 to 900 mg/L, from 200 to 800 mg/L, from 205 to 650 mg/L, from 231 to 600 mg/L, from
  • 2'Fucosyllactose is selected for a nutritional composition in an amount of from 500 to 5000 mg/L, preferably from 800 to 4000 mg/L, from 900 to 2000 mg/L, from 920 to 1700 mg/L, from 949 to 1520 mg/L, from 980 to 1500 mg/L, from 1000 to 1484 mg/L, from 1000 to 1450 mg/L, from 1200 to 1300 mg/L ,or from 1206 to 1210 mg/L of composition.
  • Lacto- N-tetraose is selected for a nutritional composition in an amount of from 200 to 4000 mg/L, more preferably from 250 to 3000 mg/L, from 300 to 1400 mg/L, from 400 to 1300 mg/L, from 490 to 1215 mg/L, from 500 to 1 138 mg/L, from 504 to 1060 mg/L, from 515 to 1000 mg/L, from 600 to 850 mg/L, from 700 to 800 mg/L, from 730 to 750 mg/L, or from 735 to 741 mg/L of composition.
  • 2'Fucosyllactose is selected for the at least one nutritional composition A in an amount of from 500 to 5000 mg/L, preferably from 900 to 4000 mg/L, more preferably from 1000 to 2000 mg/L, even more preferably from 1300 to 1700 mg/L, even more preferably from 1450 to 1520 mg/L, most preferably 1484 mg/L of composition.
  • 2'Fucosyllactose is selected for the at least one nutritional composition B in an amount of from 1000 to 1500 mg/L, preferably from 1 100 to 1300 mg/L, more preferably from 1200 to 1210 mg/L, most preferably 1206 mg/L of composition.
  • 3'Sialyllactose is selected for the at least one nutritional composition A in an amount of from 200 to 280 mg/L, preferably from 210 to 250 mg/L, more preferably from 225 to 240 mg/L, most preferably 231 mg/L of composition.
  • 6'Sialyllactose is selected for the at least one nutritional composition B in an amount of from 200 to 350 mg/L, preferably from 250 to 300 mg/L, more preferably from 270 to 280 mg/L, most preferably 275 mg/L of composition.
  • Lacto- N-neotetraose is selected for the at least one nutritional composition A in an amount of from 150 to 350 mg/L, preferably from 200 to 280 mg/L, more preferably from 220 to 255 mg/L, most preferably 239 mg/L of composition.
  • Lacto- N-tetraose is selected for the at least one nutritional composition B in an amount of from 500 to 1000 mg/L, preferably from 600 to 850 mg/L, more preferably from 730 to 750 mg/L, most preferably 741 mg/L of composition.
  • Lacto- N-tetraose is selected for the at least one nutritional composition C in an amount of from 300 to 700 mg/L, preferably from 400 to 600 mg/L, more preferably from 490 to 515 mg/L, most preferably 504 mg/L of composition.
  • the infant nutrition regimen according to the seventh aspect further comprises feeding said infant above 2 months and up to 4 months of age at least one nutritional composition C, preferably wherein the at least one nutritional composition C comprises human milk oligosaccharides (HMOs), and more preferably wherein the nutritional compositions A, B and C differ from each other in the amount of HMOs present therein.
  • HMOs human milk oligosaccharides
  • the two nutritional compositions A may be a first nutritional composition A1 for infants from 0 up to 7 days of age and a second nutritional composition A2 for infants from 8 days up to 1 month of age, or a first nutritional composition A1 for infants from 0 up to 6 days of age and a second nutritional composition A2 for infants from 7 days up to 1 month of age, or a first nutritional composition A1 for infants from 0 up to 5 days of age and a second nutritional composition A2 for infants from 6 days up to 1 month of age, or a first nutritional composition A1 for infants from 0 up to 4 days of age and a second nutritional composition A2 for infants from 5 days up to 1 month of age, or a first nutritional composition A1 for infants from 0 up to 3 days of age and a second nutritional composition A2 for infants from 4 days up to 1 month of age.
  • These nutritional compositions A1 and A2 may comprise human milk
  • the infant nutrition regimen according to the seventh aspect comprises feeding an infant from 0 up to 1 month of age three nutritional compositions A.
  • said three nutritional compositions A may be a first nutritional composition A1 for infants from 0 up to 5 days, a second nutritional composition A2 for infants from 6 up to 15 days and a third nutritional composition A3 for infants for the rest of the time period up to 1 month of age (i.e. from 16 days up to 30 or 31 days).
  • These nutritional compositions A1 , A2 and A3 preferably comprise human milk oligosaccharides (HMOs), wherein, preferably, the amounts of HMOs present in each nutritional composition A1 , A2 and A3 are selected according to the age of the infants.
  • HMOs human milk oligosaccharides
  • the third nutritional composition A3 may preferably comprise HMOs in an amount of from 500 to 4500 mg/L, preferably from 1000 to 4000 mg/L, more preferably from 2000 to 3500 mg/L, more preferably from 3000 to 3500 mg/L of the composition.
  • the nutritional compositions A e.g. A1 , A2, A3), B, C, D, E, F, etc., of the infant nutrition regimen according to the seventh aspect correspond to the nutritional compositions A (e.g. A1 , A2, A3), B, C, D, E, F, etc., according to the first aspect of the invention, respectively.
  • the invention relates to a method for providing nutrition to an infant.
  • This method may comprise:
  • the nutritional compositions A and B comprise HMOs and wherein said nutritional compositions A and B differ from each other in the amount of HMOs present therein.
  • Fig. 1 A depicts the evolving concentration of HMOs in mg/L of human milk over time.
  • Fig. 1 B depicts the evolving concentration of HMOs in mg/L of human milk over time.
  • Fig. 2 shows summary statistics of 2'Fucosyllactose concentrations in human breast milk at 1 , 2 and 4 months post partum.
  • Fig. 3 shows summary statistics of 3'Sialyllactose concentrations in human breast milk at 1 , 2 and 4 months post partum.
  • Fig. 4 shows summary statistics of Lacto-N-neotetraose concentrations in human breast milk at 1 , 2 and 4 months post partum.
  • Fig. 5 shows summary statistics of 6'Sialyllactose concentrations in human breast milk at 1 , 2 and 4 months post partum.
  • Fig. 6 shows summary statistics of Lacto-N-tetraose concentrations in human breast milk at 1 , 2 and 4 months post partum.
  • the present invention provides an age-tailored nutritional composition system for infants.
  • the nutritional composition may comprise the following micronutrients: vitamins, minerals, fiber, phytochemicals, antioxidants, prebiotics, probiotics, and any combination thereof.
  • the composition may also contain food additives such as stabilizers (when provided in solid form) or emulsifiers (when provided in liquid form).
  • protein sources based on whey, casein and mixtures thereof may be used as well as protein sources based on soy.
  • the protein source may be based on acid whey or sweet whey or mixtures thereof and may include alpha-lactalbumin and beta-lactoglobulin in any desired proportions.
  • the protein source is whey predominant (i.e. more than 50% of proteins are coming from whey proteins, such as 60% or 70%).
  • hydrolysed means in the context of the present invention a protein which has been hydrolysed or broken down into its component amino acids.
  • the proteins may be either fully or partially hydrolysed. It may be desirable to supply partially hydrolysed proteins (degree of hydrolysis between 2 and 20%), for example for infants or young children believed to be at risk of developing cow's milk allergy.
  • the hydrolysis process may be carried out as desired and as is known in the art.
  • whey protein hydrolysates may be prepared by enzymatically hydrolysing the whey fraction in one or more steps. If the whey fraction used as the starting material is substantially lactose free, it is found that the protein suffers much less lysine blockage during the hydrolysis process.
  • the extent of lysine blockage is reduced from about 15% by weight of total lysine to less than about 10% by weight of lysine; for example about 7% by weight of lysine which greatly improves the nutritional quality of the protein source.
  • at least 70% of the proteins are hydrolysed, preferably at least 80% of the proteins are hydrolysed, such as at least 85% of the proteins are hydrolysed, even more preferably at least 90% of the proteins are hydrolysed, such as at least 95% of the proteins are hydrolysed, particularly at least 98% of the proteins are hydrolysed.
  • 100% of the proteins are hydrolysed.
  • the proteins of the composition are hydrolyzed, fully hydrolyzed or partially hydrolyzed.
  • the degree of hydrolysis (DH) of the protein can be between 8 and 40, or between 20 and 60 or between 20 and 80 or more than 10, 20, 40, 60, 80 or 90.
  • the nutritional composition is a hypoallergenic nutritional composition.
  • the nutritional composition generally contains a carbohydrate source. This is particularly preferable in the case where the nutritional composition of the invention is an infant formula.
  • any carbohydrate source conventionally found in infant formulae such as lactose, sucrose, maltodextrin, starch and mixtures thereof may be used although one of the preferred sources of carbohydrates is lactose.
  • the nutritional composition generally contains a source of lipids. This is particularly relevant if the nutritional composition of the invention is an infant formula.
  • the lipid source may be any lipid or fat which is suitable for use in infant formulae. Some suitable fat sources include palm oil, high oleic sunflower oil and high oleic safflower oil.
  • the essential fatty acids linoleic and a-linolenic acid may also be added, as well small amounts of oils containing high quantities of preformed arachidonic acid and docosahexaenoic acid such as fish oils or microbial oils.
  • the fat source may have a ratio of n-6 to n-3 fatty acids of about 5:1 to about 15:1 ; for example about 8:1 to about 10:1 .
  • the nutritional composition may also contain all vitamins and minerals understood to be essential in the daily diet and in nutritionally significant amounts. Minimum requirements have been established for certain vitamins and minerals.
  • minerals, vitamins and other nutrients optionally present in the composition of the invention include vitamin A, vitamin B1 , vitamin B2, vitamin B6, vitamin B12, vitamin E, vitamin K, vitamin C, vitamin D, folic acid, inositol, niacin, biotin, pantothenic acid, choline, calcium, phosphorous, iodine, iron, magnesium, copper, zinc, manganese, chlorine, potassium, sodium, selenium, chromium, molybdenum, taurine, and L- carnitine. Minerals are usually added in salt form.
  • the nutritional composition may contain emulsifiers and stabilisers such as soy, lecithin, citric acid esters of mono- and diglycerides, and the like.
  • the nutritional composition may contain probiotics.
  • probiotic means microbial cell preparations or components of microbial cells with a beneficial effect on the health or well-being of the host.
  • the microbial cells are generally bacteria or yeasts.
  • probiotic microorganisms most commonly used are principally bacteria and yeasts of the following genera: Lactobacillus spp., Streptococcus spp., Enterococcus spp., Bifidobacterium spp. and Saccharomyces spp. In some particular
  • the probiotic is a probiotic bacterial strain. In some specific embodiments, the probiotic is a probiotic bacterial strain.
  • Bifidobacterium lactis CNCM 1 -3446 sold inter alia by the Christian Hansen company of Denmark under the trademark Bb 12, Bifidobacterium longum ATCC BAA-999 sold by
  • Bifidobacterium breve sold by Danisco under the trademark Bb-03 Bifidobacterium breve sold by Morinaga under the trade mark M-16V, Bifidobacterium infantis sold by Procter & Gamble Co. under the trademark Bifantis and Bifidobacterium breve sold by Institut Rosell (Lallemand) under the trademark R0070.
  • the nutritional composition can further comprise at least one non-digestible oligosaccharide (e.g. prebiotics) other than the human milk oligosaccharides previously mentioned.
  • prebiotics include certain oligosaccharides, such as fructooligosaccharides (FOS), galactooligosaccharides (GOS) and/or bovine's milk derived oligosaccharides (BMOs). They are usually in an amount between 0.3 and 10% by weight of composition. They may be in an amount between 2 and 8 g/l reconstituted nutritional composition (e.g. reconstituted formula).
  • the nutritional composition may be in the form of a nutritional product, preferably a food product, a nutritional supplement, a full meal, a nutritionally complete formula, a pharmaceutical formulation, functional food, a beverage product, and combinations thereof.
  • the nutritional composition is a "synthetic nutritional composition” (i.e. not breast milk).
  • synthetic composition means a mixture obtained by chemical and/or biological means, which may be chemically identical to the mixture naturally occurring in mammalian milks.
  • the nutritional composition of the invention is in the form of a nutritional product which is adapted to the needs of an infant, such as an infant formula.
  • infant formula means a nutritional product intended for particular nutritional use by infants during the first 12 months of life, which satisfies the nutritional requirements of said infants. It has to be
  • infant formula can be either a complete or a partial substitute for human milk, i.e. that infants can be fed with the infant formula alone, or that the infant formula can be used as a complement of human milk.
  • infant formulae it is referred to the Commission Directives 2006/141/EC of 22 December 2006 and/or 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae, Article 1 .2 (c).
  • the expression "infant formula” encompasses both the "starter infant formula", i.e. a foodstuff intended for particular nutritional use by infants during the first four months of life and the "follow-on formula", i.e. a foodstuff intended for particular nutritional use by infants aged over four months and constituting the principal liquid element in the progressively diversified diet of this category of person.
  • the term "nutritional composition system” relates to a selection or range of at least two individual nutritional compositions according to the invention.
  • the nutritional composition system can be in the form of a nutritional product range or a range of nutritional products comprising at least two individual nutritional products, wherein each nutritional product of said range comprises an individual nutritional composition according to the invention.
  • the nutritional composition system of the invention relates to a nutritional product range, wherein the nutritional products are infant formulae.
  • infant formulae may be formulated such that they provide either a complete or a partial substitute for human milk.
  • HMO human milk oligosaccharide(s). These carbohydrates are highly resistant to digestive enzymatic hydrolysis, indicating that they may display essential functions not directly related to their caloric value. It has especially been illustrated that they play a vital role in the early development of infants and young children, such as the maturation of the immune system. Many different kinds of HMOs are found in the human milk.
  • Each individual oligosaccharide is based on a combination of glucose, galactose, sialic acid (N-acetylneuraminic acid), fucose and/or N-acetylglucosamine with many and varied linkages between them, thus accounting for the enormous number of different oligosaccharides in human milk - over 130 such structures have been identified so far. Almost all of them have a lactose moiety at their reducing end while sialic acid and/or fucose (when present) occupy terminal positions at the non-reducing ends.
  • the HMOs can be acidic (e.g. charged sialic acid containing oligosaccharide) or neutral (e.g.
  • the HMOs comprised in the nutritional composition system of the invention are preferably "sialylated oligosaccharides", “fucosylated oligosaccharides”, “N- acetylated oligosaccharides” or any mixtures thereof.
  • a "sialylated oligosaccharide” is a charged sialic acid containing oligosaccharide, i.e. an oligosaccharide having a sialic acid residue. It has an acidic nature.
  • Some examples are 3-SL (3' sialyllactose) and 6-SL (6' sialyllactose). They may be isolated by chromatographic or filtration technology from a natural source such as animal milks. Alternatively, they may be produced by biotechnological means using specific sialyltransferases or sialidases, neuraminidases, either by an enzyme based fermentation technology (recombinant or natural enzymes), by chemical synthesis or by a microbial fermentation technology.
  • Some examples are 2-FL (2' fucosyllactose), 3-FL (3- fucosyllactose), difucosyllactose, lacto-N-fucopentaose (e.g. lacto-N-fucopentaose I, lacto-N-fucopentaose II, lacto-N-fucopentaose III, lacto-N-fucopentaose V), lacto-N- fucohexaose, lacto-N-difucohexaose I, fucosyllacto-N-hexaose, fucosyllacto-N- neohexaose, difucosyllacto-N-hexaose I, difucosyllacto-N-neohexaose II and any combination thereof. In a preferred embodiment, it is 2-FL.
  • oligosaccharide may be isolated by chromatography or filtration technology from a natural source such as animal milks. Alternatively, it may be produced by
  • microbes may either express their natural enzymes and substrates or may be engineered to produce respective substrates and enzymes.
  • Single microbial cultures and/or mixed cultures may be used.
  • fucosylated oligosaccharides may be produced by chemical synthesis from lactose and free fucose. Fucosylated oligosaccharides are also available for example from Kyowa, Hakko, Kogyo of Japan.
  • the total amount of human milk oligosaccharides (HMOs) comprised in the nutritional compositions of the invention preferably ranges from 500 to 10000 mg/L, more preferably from 1000 to 8000 mg/L, from 1500 to 5000 mg/L, from 1800 to 4000 mg/L, from 1863 to 3673 mg/L, from 1883 to 3632 mg/L, from 1902 to 3590 mg/L, from 2000 to 3500mg/L, from 2500 to 3000 mg/L, or from 2558 to 2602 mg/L of composition.
  • the HMOs comprised in the nutritional compositions of the invention are selected from HMOs which are naturally present in human breast milk.
  • 2'Fucosyllactose may be present in a nutritional composition of the invention in an amount of from 500 to 5000 mg/L of composition.
  • 2'Fucosyllactose may be present in said nutritional composition in amount of from 800 to 4000 mg/L, from 900 to 2000 mg/L, from 920 to 1700 mg/L, from 949 to 1520 mg/L, from 980 to 1500 mg/L, from 1000 to 1484 mg/L, from 1000 to 1450 mg/L, from 1200 to 1300 mg/L, or from 1206 to 1210 mg/L of composition.
  • the 3'-Siallylactose (3'-SL) and 6'-Siallylactose (6'-SL) may be comprised in a nutritional composition in a weight ratio between 6:1 and 1 :10, preferably between 5.9:1 and 1 .5:10, such as between 5.86:1 and 1 .53:10, for example in a ratio of 1 :1 .
  • the 3'-Siallylactose (3'-SL) and 6'-Siallylactose (6'-SL) may be comprised in the nutritional compositions of the age-tailored nutritional composition system in a weight ratio that may evolve over time, for example in a similar way than the evolution of this ratio in the human breast milk.
  • the 3'SL:6'SL ratio may be 1 .53:10 in the at least one nutritional composition A, then the 3'SL amount (and therefore also the3'SL:6'SL ratio) may progressively increase in compositions B, C and in any other compositions (D, E, F).
  • the individual nutritional compositions of the invention differ from each other in the amount of HMOs present therein.
  • the age-tailored nutritional composition system of the invention comprises at least one nutritional composition A for infants from 0 up to 1 month of age, and at least one nutritional composition B for infants above 1 month and up to 2 months of age, wherein said nutritional compositions A and B differ from each other in the amount of HMOs present therein. Since the amount of HMOs in human milk decreases over time, the amount of HMOs present in the at least one nutritional composition A preferably exceeds the amount of HMOs present in the at least one nutritional composition B.
  • the expression “at least one nutritional composition” means that said system may comprise more than one of a particular nutritional composition.
  • “at least one nutritional composition A” means that the system may comprise from 1 to 100, from 2 to 50, from 4 to 30, from 5 to 20, from 6 to 10 individual compositions A, or from 1 to 10, from 1 to 8, from 1 to 6, from 1 to 4, from 1 to 3 individual compositions A, such as 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10 or more nutritional compositions A.
  • the present age-tailored nutritional composition system is therefore adapted to the HMOs requirements of the developing infant and provides the "right concentration" of HMOs "at the right time”.
  • this nutritional composition is age-tailored; that it addresses the needs of the infants for this specific period of age; that it is adapted for the needs of the infants for this specific period of age; that it is intended to be administered (or fed or given) to infants of this period of age; that it is to be administered (or fed or given) to infants of this period of age and/or that it will be administered (or fed or given) to infants of this period of age.
  • the age-tailored nutritional composition system of the invention further comprises at least one HMOs-containing nutritional composition C for infants above 2 months and up to 4 months of age.
  • said at least one composition C differs from compositions A and B in the amount of HMOs present therein.
  • the amount of HMOs present in the at least one composition C is preferably lower than the amounts of HMOs present in each of the at least one nutritional composition A and the at least one nutritional composition B.
  • the amounts of HMOs present in composition C are preferably selected according to the age of the infants. Typically, said amounts are selected such that they reflect the HMOs profile in human milk from the second and up to the fourth months of breast feeding.
  • including the third nutritional composition C into the age-tailored nutritional composition system of the invention may provide a still enhanced adaptation of this system to the evolving HMOs requirements of the developing infant.
  • the at least one nutritional composition A for infants from 0 up to 1 month of age may comprise HMOs in an amount of from 1000 to 10000 mg/L, preferably from 1500 to 8000 mg/L, more preferably from 2000 to 5000 mg/L of said composition, even more preferably in an amount of from 3000 to 4000 mg/L, even more preferably from 3590 to 3673 mg/L, and most preferably in an amount of 3632 mg/L of said composition.
  • the at least one composition A may comprise 2'Fucosyllactose in an amount of from 500 to 5000 mg/L, preferably from 900 to 4000 mg/L, more preferably from 1000 to 2000 mg/L, even more preferably from 1300 to 1700 mg/L, more preferably from 1450 to 1520 mg/L, most preferably 1484 mg/L of composition; 3'Sialyllactose in an amount of from 200 to 280 mg/L, preferably from 210 to 250 mg/L, more preferably from 225 to 240 mg/L, most preferably 231 mg/L of
  • composition 6'Sialyllactose in an amount of from 450 to 650 mg/L, preferably from 500 to 600 mg/L, more preferably from 530 to 550 mg/L, most preferably 540 mg/L of composition; Lacto-N-neotetraose in an amount of from 150 to 350 mg/L, preferably from 200 to 280 mg/L, more preferably from 220 to 255 mg/L, most preferably 239 mg/L of composition; and / or Lacto-N-tetraose in an amount of from 600 to 4000 mg/L, preferably from 700 to 3000 mg/L, more preferably from 800 to 1400 mg/L, even more preferably from 1000 to 1300 mg/L, even more preferably from 1060 to 1215 mg/L, most preferably 1 138 mg/L of composition.
  • the at least one composition A comprises a HMOs blend comprising 2'Fucosyllactose, 3'Sialyllactose, 6'Sialyllactose, Lacto-N-neotetraose and Lacto-N-tetraose. It is particularly preferred that said blend comprises
  • composition A 2'Fucosyllactose, 3'Sialyllactose, 6'Sialyllactose, Lacto-N-neotetraose and Lacto-N- tetraose in the amounts defined above for composition A.
  • the at least one nutritional composition B for infants above 1 month and up to 2 months of age may comprise HMOs in an amount of from 1500 to 3500 mg/L of said composition, and preferably from 2000 to 3000 mg/L, more preferably from 2558 to 2602 mg/L, and most preferably in an amount of 2580 mg/L of said composition. More specifically, the at least one composition B may comprise 2'Fucosyllactose in an amount of from 1000 to 1500 mg/L, preferably from 1 100 to 1300 mg/L, more preferably from 1200 to 1210 mg/L, most preferably 1206 mg/L of composition;
  • 3'Sialyllactose in an amount of from 150 to 250 mg/L, preferably from 190 to 230 mg/L, more preferably from 200 to 225 mg/L, most preferably 21 1 mg/L of
  • composition 6'Sialyllactose in an amount of from 200 to 350 mg/L, preferably from 250 to 300 mg/L, more preferably from 270 to 280 mg/L, most preferably 275 mg/L of composition; Lacto-N-neotetraose in an amount of from 100 to 200 mg/L, preferably from 120 to 180 mg/L, more preferably from 130 to 165 mg/L, most preferably 148 mg/L of composition; and/or Lacto-N-tetraose in an amount of from 500 to 1000 mg/L, preferably from 600 to 850 mg/L, more preferably from 730 to 750 mg/L, most preferably 741 mg/L of composition.
  • the at least one composition B comprises a HMOs blend comprising 2'Fucosyllactose, 3'Sialyllactose, 6'Sialyllactose, Lacto-N-neotetraose and Lacto-N-tetraose. It is particularly preferred that said blend comprises
  • the at least one composition C may comprise 2'Fucosyllactose in an amount of from 800 to 1200 mg/L, preferably from 900 to 1000 mg/L, more preferably from 920 to 980 mg/L, most preferably 949 mg/L of composition;
  • At least one nutritional composition D for infants above 4 months of age, and, optionally, any further nutritional compositions E, F, etc.
  • this at least one nutritional composition D and the optional further nutritional compositions (E, F, etc.) may comprise HMOs, wherein the at least one composition D and the optional further nutritional compositions (E, F, etc.) preferably differ from nutritional
  • said amounts are selected such that they reflect the HMOs profile in human milk from the fourth months of breast feeding up to the end of the lactation period, and preferably the fourth months of breast feeding up to 5, 6, 7, 8, 9, 10, 1 1 , or 12 months of breast feeding.
  • Including at least one nutritional composition D and, optionally, further nutritional compositions (E, F, etc.) into the age-tailored nutritional composition system of the invention may provide a still enhanced adaptation of this system to the evolving HMOs requirements of the developing infant.
  • both nutritional compositions A1 and A2 comprise HMOs, wherein the amounts of HMOs present in each nutritional composition A1 and A2 are selected according to the age of the infants.
  • the amount of HMOs present in nutritional composition A1 exceeds the amount of HMOs present in nutritional composition A2, and that the amount of HMOs present in nutritional composition A2 exceeds the amount of HMOs present in nutritional composition A3.
  • Said first nutritional composition A1 may preferably comprise HMOs in a total amount of from 5000 to 10000 mg/L, and more preferably from 5000 to 8000 mg/L of composition.
  • each of these nutritional compositions A (e.g. A1 , A2, A3), B, C, D, E, F, etc., comprises a HMOs blend comprising 2'Fucosyllactose, 3'Sialyllactose, 6'Sialyllactose, Lacto-N-neotetraose and Lacto-N-tetraose in the amounts given above.
  • HMOs blend comprising 2'Fucosyllactose, 3'Sialyllactose, 6'Sialyllactose, Lacto-N-neotetraose and Lacto-N-tetraose in the amounts given above.
  • the kit may comprise a set of the nutritional composition B of the invention in a quantity that is sufficient for feeding an infant from 1 month and up to 2 months of age.
  • the infant nutrition kit of the invention comprises two nutritional compositions A, namely the first nutritional composition A1 and the second nutritional composition A2 as described above.
  • the first nutritional composition A1 may be comprised in the present infant nutrition kit in a quantity that is sufficient for feeding an infant from its birth up to the first 3 to 7 days after birth and the second nutritional composition A2 may be comprised in said kit in a quantity that is sufficient for feeding said infant for the remaining period of up to 1 month after birth.
  • the single dose units may also be in the form of stick packs (blister packs) sachets.
  • the individual nutritional compositions being part of the infant nutrition kit of the invention may be packed into individual capsules and presented to the consumer in multipacks containing a sufficient number of capsules to meet the requirements of an infant over a period of time, e.g. one week or one month.
  • the kit may comprise a certain quantity of single dose units comprising a sufficient amount of nutritional composition A, e.g. from 1 to 60, from 2 to 50, from 3 to 40, from 4 to 30, from 5 to 20, from 6 to 15, from 7 to 12, or from 8 to 10 single dose units comprising a sufficient amount of nutritional composition A.
  • a sufficient amount of nutritional composition A e.g. from 1 to 60, from 2 to 50, from 3 to 40, from 4 to 30, from 5 to 20, from 6 to 15, from 7 to 12, or from 8 to 10 single dose units comprising a sufficient amount of nutritional composition A.
  • the kit may also comprise a certain quantity of single dose units comprising a sufficient amount of nutritional composition C, e.g. from 1 to 60, from 2 to 50, from 3 to 40, from 4 to 30, from 5 to 20, from 6 to 15, from 7 to 12, or from 8 to 10 single dose units comprising a sufficient amount of nutritional composition C.
  • a sufficient amount of nutritional composition C e.g. from 1 to 60, from 2 to 50, from 3 to 40, from 4 to 30, from 5 to 20, from 6 to 15, from 7 to 12, or from 8 to 10 single dose units comprising a sufficient amount of nutritional composition C.
  • the kit may also comprise a certain quantity of single dose units comprising a sufficient amount of nutritional composition D or E or F, etc. in the above-named amounts.
  • composition A At least one nutritional composition is prepared, which is specifically adapted to the nutritional needs of infants from 0 up to 1 month of age
  • composition B At least one other nutritional composition which is specifically adapted to the nutritional needs of infants above 1 month and up to 2 months of age
  • the nutritional compositions may be manufactured in any suitable manner.
  • the nutritional compositions may be prepared by blending together a protein source, a carbohydrate source, and a fat source in appropriate proportions. If used, emulsifiers may be included in the blend. Vitamins and minerals may be added at this point but are usually added later to avoid thermal degradation. Any lipophilic vitamins, emulsifiers and the like may be dissolved into the fat source prior to blending. Water, preferably water which has been subjected to reverse osmosis, may then be mixed in to form a liquid mixture.
  • the liquid mixture may then be cooled to about 60°C to about 85°C for example by flash cooling.
  • the liquid mixture may then be homogenised for example in two stages at about 7 MPa to about 40 MPa in the first stage and about 2 MPa to about 14 MPa in the second stage.
  • the homogenised mixture may then be further cooled to add any heat sensitive components such as vitamins and minerals.
  • the pH and solids content of the homogenised mixture are conveniently standardised at this point.
  • the homogenised mixture may be transferred to a suitable drying apparatus such as a spray drier or freeze drier and converted to powder.
  • the powder should have a moisture content of less than about 3% by weight. Alternatively, the homogenized mixture is concentrated.
  • the second step of the method further comprises selecting an amount of HMOs for the at least one further nutritional composition C according to the age of the infants.
  • an amount of HMOs is selected for each of the compositions A, B and C, such that these nutritional compositions differ from each other in the amount of HMOs present therein.
  • the amount of HMOs is selected for the at least one nutritional composition A such that it exceeds the amount of HMOs that is selected for the at least one nutritional composition B, and, optionally, the amount of HMOs is selected for the at least one composition B such that it exceeds the amount of HMOs that is selected for the at least one nutritional composition C.
  • the first step of the present method further comprises preparing at least one further nutritional composition, which is specifically adapted to the nutritional needs of infants above 4 months of age, such as for example to the nutritional needs of infants from 4 months of age up to 5, 6, 7, 8, 9, 10, 1 1 , or 12 months of age (composition D).
  • the second step of the method may further comprise selecting an amount of HMOs for the at least one further nutritional composition D according to the age of the infants, wherein this amount preferably differs from the amount of HMOs selected for each one of compositions A, B and C, more preferably such that the amount selected for each one of compositions A, B and C exceeds the amount selected for nutritional composition D.
  • the first step of the present method may further comprise preparing further nutritional compositions that are specifically adapted to the nutritional needs of infants above 4 months of age, and preferably to the nutritional needs of infants from 5 up to 12 months, from 6 up to 1 1 months, from 7 up to 10 months, from 8 up to 9 months of age (compositions E, F, etc.).
  • the second step of the method may further comprise selecting an amount of HMOs for each one of the further nutritional compositions E, F, etc.
  • these amounts preferably differ from each other and also differ from the amount of HMOs selected for each one of compositions A, B, C and D, more preferably such that the amount selected for each one of compositions A, B, C and D, exceeds the amount selected for nutritional composition E, the amount selected for compositions E, exceeds the amount selected for nutritional composition F, the amount selected for compositions F exceeds the amount selected for nutritional composition G, etc.
  • the first step of preparing at least one nutritional composition adapted to the nutritional needs of infants from 0 up to 1 month of age comprises preparing two different nutritional compositions, namely a first nutritional composition, which is specifically adapted to the nutritional needs of infants from the first 3 to 7 days of age (composition A1 ) and a second nutritional composition which is specifically adapted to the nutritional needs of infants in the remaining period up to 1 month of age (composition A2).
  • the second step of the method further comprises selecting an amount of HMOs for each of the nutritional compositions A1 and A2 according to the age of the infants, more preferably wherein said amount of HMOs is selected such that nutritional compositions A1 and A2 differ from each other in the amount of HMOs present therein. It is particularly preferred that for each of nutritional compositions A1 and A2 the amount of HMOs is selected such that the amount of HMOs selected for nutritional composition A1 exceeds the amount of HMOs selected for nutritional composition A2.
  • HMOs may be selected for any of the above nutritional
  • compositions in a total amount of from 500 to 10000 mg/L, preferably from 1000 to 8000 mg/L, from 1500 to 5000 mg/L or from 1800 to 4000 mg/L of composition.
  • the HMOs are present in a nutritional composition in a total amount of from 1863 to 3673 mg/L, from 1883 to 3632 mg/L, from 1902 to 3590 mg/L, from 2000 to 3500mg/L, from 2500 to 3000 mg/L, from 2558 to 2602 mg/L or in an amount of 2580mg/L of composition, depending on the age of the infants.
  • the HMOs may be particularly selected from “sialylated oligosaccharides", “fucosylated oligosaccharides”, “N-acetylated oligosaccharides” or any mixtures thereof, and preferably from HMOs which are naturally present in human breast milk such as 2'Fucosyllactose (2'FL or 2FL or 2-FL), 3'Sialyllactose (3'SL or 3SL or 3-SL), 6'Sialyllactose (6'SL or 6SL or 6-SL), Lacto-N-neotetraose (LNnT), Lacto-N-tetraose (LNT), or any combination thereof.
  • HMOs which are naturally present in human breast milk such as 2'Fucosyllactose (2'FL or 2FL or 2-FL), 3'Sialyllactose (3'SL or 3SL or 3-SL), 6'Sialyllactose (6'SL or 6SL or 6-
  • the amount of HMOs selected in the second step of said method is incorporated into the corresponding nutritional composition.
  • the HMOs may be added to the powdered nutritional compositions prepared in the first step by dry mixing.
  • the HMOs may be added at an earlier stage during preparation of the nutritional compositions, for example by blending together with the protein source, carbohydrate source, and fat source.
  • a skilled person is able to determine when the incorporation of the HMOs into the nutritional compositions should occur.
  • a further amount of HMOs is selected according to the specific HMOs requirements of infants above 2 months and up to 4 months of age.
  • the amounts of the protein source, the carbohydrate source, and the fat source are specifically adapted to the nutritional needs of infants above 1 month and up to 2 months of age,
  • carbohydrate source and the fat source are specifically adapted to the nutritional needs of infants having the respective age.
  • the first step of the alternative embodiment may also comprise selecting two different amounts of HMOs according to the specific HMOs requirements of infants from 0 up to 1 month of age.
  • said first step may comprises selecting a first amount of HMOs according to the specific HMOs requirements of infants for the first 3 to 7 days of age and selecting a second amount of HMOs according to the specific HMOs requirements of infants in the remaining period of up to 1 month of age.
  • the nutritional composition blends may be further processed as described above. For instance, emulsifiers, vitamins, minerals and water may be included in the blend to form a liquid mixture. The liquid mixture may then be thermally treated, cooled, homogenised and dried or concentrated as described above.
  • the HMOs comprised in nutritional compositions A are preferably selected from "sialylated
  • nutritional compositions A e.g. A1 , A2, A3), B, C, D, E, etc. disclosed herein.
  • These different nutritional compositions A e.g. A1 , A2, A3), B, C, D, E, etc. are sequentially administered and there is no overlap of times of administration of the different nutritional compositions A (e.g. A1 , A2, A3), B, C, D, E, etc.
  • compositions can also be administered during the entire specific window of time, or during only a part thereof, and the administration can be continuous or not.
  • infant nutrition regimen may include feeding the infants with complementary foods.
  • complementary foods may be any of the foods commercially available for the corresponding age range. These complementary foods can be for example pureed vegetables, meats, fish, fruits.
  • the invention further relates to a method for providing nutrition to an infant.
  • Vit. B1 (mg) 0.07 to 0.1 0.07 to 0.1 0.07 to 0.1 0.07 to 0.1 0.07 to 0.1 0.07 to 0.1
  • Example 2 Age-tailored set of nutritional compositions
  • composition A B C D Composition A B C D
  • Example 3 Clinical trial on normal ranges of human milk oligosaccharides in breast milk of healthy mothers
  • Subjects representing one or more of the following criteria are excluded from participation in the study: 1 . Gestational diabetes, 2. HTA > 140/90, 3. Mothers who are smokers while breast-feeding, 4. Subject who cannot be expected to comply with the study procedures.5. Currently participating or having participated in another clinical trial during the last 12 weeks prior to the beginning of this study. HMOs sample preparation and analysis
  • HMOs analysis was conducted in duplicates on a 1 ml_ sample of whole breast milk, corresponding to a complete feed, and taken after 30, 60 and 120 days after infants' birth (post partum). 3'-Sialyllactose and 6'-Sialyllactose were recorded at several stages and up to 240 days after infants' birth
  • HPAEC Thermo, Dionex, Ca
  • CarboPac PA1 column Thermo, Dionex, Ca
  • PAD pulsed amperometric detector
  • Data collection points were 1 , 2 and 4 months after infants' birth. Longitudinal analysis was carried out using linear mixed models. Adjusted R-squares are computed to obtain the degree of variability that is explained by the statistical models used. Where appropriate P-values for testing differences between genders and time points have been computed.
  • V1 , V2 and V3 determine post partum days 30, 60 and 120, respectively.
  • the absolute HMOs concentration in human breast milk decreases with time as determined after 30, 60 and 120 days after infants' birth.
  • HMOs concentrations were calculated from all samples including those with very low 2'FL levels ( ⁇ 100mg/L, which are presumed non- secretors).
  • Fig. 1 B the HMOs concentrations were calculated from samples comprising 2'Fucosyllactose (2'FL) > 100mg/L.
  • 2'Fucosyllactose, 3'Sialyllactose, 6'Sialyllactose, Lacto-N-neotetraose, Lacto-N- tetraose decrease within 30, 60 and 120 days after infants' birth.
  • the weight ratio of 3'-Sialyllactose and 6'- Sialyllactose in human breast milk increases with time as determined after 1 1 , 30, 60,120 and 240 days after infants' birth. While at the very beginning of the lactation period the 3'SL/6'SL ratio is about 1 .53:10 with 6'SL as the major portion of sialyllactose in human breast milk, said ratio shifts with time towards about 5.86:1 with 3'SL as the major portion of sialyllactose in human breast milk after 8 months post partum. Further, the mean weight ratio of 3'-Sialyllactose and 6'-Sialyllactose in human breast milk during the lactation period was found to be about 1 :1 .
  • Example 3 clearly demonstrates that the age-tailored nutritional composition system of the present invention provides HMOs in ranges matching closely the mother's milk physiological levels, and, in particular, takes into account the evolving nutritional needs of infants in at least the first 2 months of life of the infants.

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Abstract

La présente invention concerne un système de composition nutritive adaptée à l'âge comprenant un niveau adaptatif d'oligosaccharides de lait humain (HMO), et un procédé de préparation dudit système. Ledit système de composition nutritive adaptée à l'âge comprend au moins deux compositions nutritionnelles pour nourrissons d'un certain âge, qui diffèrent entre elles en ce qui concerne la quantité de HMO qu'elles contiennent. Ce système est spécifiquement adapté aux besoins nutritionnels en évolution des nourrissons, de leur naissance jusqu'à la fin de l'allaitement.
PCT/EP2015/071930 2014-09-25 2015-09-24 Système de préparation pour nourrissons avec niveaux adaptatifs d'oligosaccharides de lait humain WO2016046294A1 (fr)

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RU2017113997A RU2761533C2 (ru) 2014-09-25 2015-09-24 Система детской смеси с адаптивными концентрациями олигосахаридов грудного молока (огм)
ES15771909T ES2725464T3 (es) 2014-09-25 2015-09-24 Sistema de fórmula infantil con niveles adaptativos de oligosacáridos de leche humana (OLH)
US15/514,145 US10820616B2 (en) 2014-09-25 2015-09-24 Infant formula system with adaptive levels of human milk oligosaccharides (HMOs)
BR112017003920A BR112017003920A2 (pt) 2014-09-25 2015-09-24 sistema de fórmulas infantis para lactentes com teores adaptativos de oligossacarídeos de leite humano (hmos)
AU2015323762A AU2015323762A1 (en) 2014-09-25 2015-09-24 Infant formula system with adaptive levels of human milk oligosaccharides (HMOs)
CN201580051698.2A CN106714583A (zh) 2014-09-25 2015-09-24 具有自适应水平的人乳寡糖(hmo)的婴儿配方食品体系
EP15771909.7A EP3197295B1 (fr) 2014-09-25 2015-09-24 Système de préparation pour nourrissons avec des niveaux adaptatifs d'oligosaccharides du lait humain (hmo)
MX2017003441A MX2017003441A (es) 2014-09-25 2015-09-24 Sistema de formulas infantiles con niveles adaptables de oligosacaridos de la leche humana (hmo).
PH12017500174A PH12017500174A1 (en) 2014-09-25 2017-01-30 INFANT FORMULA SYSTEM WITH ADAPTIVE LEVELS OF HUMAN MILK OLIGOSACCHARIDES (HMOs)
AU2020201932A AU2020201932A1 (en) 2014-09-25 2020-03-18 Infant formula system with adaptive levels of human milk oligosaccharides (HMOs)

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WO2018024870A1 (fr) * 2016-08-04 2018-02-08 Nestec S.A. Compositions nutritionnelles contenant du 2fl et du lnnt destinées à être utilisées dans la prévention et/ou le traitement de la diarrhée non-rotavirus agissant sur la dysbiose du microbiote intestinal
WO2018069534A1 (fr) * 2016-10-14 2018-04-19 Mead Johnson Nutrition Company Produits nutritionnels pédiatriques personnalisés comprenant des oligosaccharides de lait humain
WO2018206434A1 (fr) * 2017-05-09 2018-11-15 Nestec S.A. Production synergique de butyrate associée à la complexité d'un mélange de hmo pour une utilisation chez des nourrissons ou de jeunes enfants à des fins sanitaires
EP3197295B1 (fr) 2014-09-25 2019-03-06 Nestec S.A. Système de préparation pour nourrissons avec des niveaux adaptatifs d'oligosaccharides du lait humain (hmo)
WO2019215302A1 (fr) * 2018-05-09 2019-11-14 Mjn U.S. Holdings Llc Complément de bien-être pour nutrition maternelle post-partum
JP2020505384A (ja) * 2017-01-20 2020-02-20 パルスズキエウィクズ，ピョートル 小児の経口供給および／または経腸供給のための調製物の改善された製剤
KR102241938B1 (ko) * 2020-09-14 2021-04-20 (주)에이피테크놀로지 2'-푸코실락토오스를 포함하는 뇌심혈관 질환 개선용 식품 조성물
WO2021116236A1 (fr) * 2019-12-11 2021-06-17 Mjn U.S. Holdings Llc Compositions nutritionnelles adaptées à diférents âges, comprenant des oligosaccharides de lait humain et leurs utilisations
WO2021115990A1 (fr) * 2019-12-09 2021-06-17 Société des Produits Nestlé S.A. Compositions comprenant des oligosaccharides de lait humain destinées à être utilisées chez un sujet pour aider au développement du langage
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WO2022129518A1 (fr) * 2020-12-18 2022-06-23 Société des Produits Nestlé S.A. Compositions nutritionnelles synthétiques adaptées aux nourrissons chinois
RU2782199C2 (ru) * 2016-08-04 2022-10-24 Сосьете Де Продюи Нестле С.А. Питательные композиции с 2fl и lnnt для применения в профилактике и/или лечении не-ротавирусной диареи путем воздействия на дисбиоз кишечной микробиоты
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AU2017213082B2 (en) * 2016-01-26 2021-07-01 Société des Produits Nestlé S.A. Compositions comprising human milk oligosaccharides for use in infants or young children to prevent or treat allergies
WO2017129640A1 (fr) * 2016-01-26 2017-08-03 Nestec S.A. Compositions comprenant des oligosaccharides de lait humain destinées à être utilisées chez des nourrissons ou des jeunes enfants pour prévenir ou traiter des allergies
WO2017129639A1 (fr) * 2016-01-26 2017-08-03 Nestec S.A. Compositions comprenant des oligosaccharides du lait humain destinés à être utilisées chez des nourrissons ou de jeunes enfants pour prévenir ou traiter un trouble de santé par augmentation de la sécrétion de glp-1
WO2017129650A1 (fr) * 2016-01-26 2017-08-03 Nestec S.A. Compositions comprenant 2 fl et lnnt pour utilisation chez des nourrissons ou de jeunes enfants pour prévenir ultérieurement dans la vie l'obésité ou des comorbidités associées
US11224651B2 (en) 2016-01-26 2022-01-18 Societe Des Produits Nestle S.A. Compositions comprising human milk oligosaccharides for use in infants or young children to prevent or treat allergies
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CN109562117A (zh) * 2016-08-04 2019-04-02 雀巢产品技术援助有限公司 具有2FL和LNnT的营养组合物，用于通过作用于肠道微生物群生态失调来预防和/或治疗非轮状病毒腹泻
CN109890222A (zh) * 2016-10-14 2019-06-14 Mjn 美国控股有限责任公司 包含人乳低聚糖的个性化儿科营养产品
WO2018069534A1 (fr) * 2016-10-14 2018-04-19 Mead Johnson Nutrition Company Produits nutritionnels pédiatriques personnalisés comprenant des oligosaccharides de lait humain
AU2017341402B2 (en) * 2016-10-14 2020-10-22 Mjn U.S. Holdings Llc Personalized pediatric nutrition products comprising human milk oligosaccharides
EP3573482B1 (fr) 2017-01-20 2021-12-01 Paluszkiewicz, Piotr Formule améliorée de préparations pour l'alimentation orale et/ou entérique d'enfants
EP3573482A4 (fr) * 2017-01-20 2021-01-27 Paluszkiewicz, Piotr Formule améliorée de préparations pour l'alimentation orale et/ou entérique d'enfants
JP7360326B2 (ja) 2017-01-20 2023-10-12 パルスズキエウィクズ，ピョートル 小児の経口供給および／または経腸供給のための調製物の改善された製剤
JP2020505384A (ja) * 2017-01-20 2020-02-20 パルスズキエウィクズ，ピョートル 小児の経口供給および／または経腸供給のための調製物の改善された製剤
US11253530B2 (en) 2017-05-09 2022-02-22 Societe Des Produits Nestle S.A. Synergistic production of butyrate associated with the complexity of HMOS blend for use in infants or young children for health purposes
RU2769462C2 (ru) * 2017-05-09 2022-03-31 Сосьете Де Продюи Нестле С.А. Синергетическая выработка бутирата, связанная со сложностью смеси огм для применения у младенцев или детей младшего возраста в медицинских целях
WO2018206434A1 (fr) * 2017-05-09 2018-11-15 Nestec S.A. Production synergique de butyrate associée à la complexité d'un mélange de hmo pour une utilisation chez des nourrissons ou de jeunes enfants à des fins sanitaires
AU2018265066B2 (en) * 2017-05-09 2023-10-19 Societe Des Produits Nestle S.A. Synergistic production of butyrate associated with the complexity of HMOs blend for use in infants or young children for health purposes
US11524019B2 (en) 2017-08-21 2022-12-13 Glycom A/S Synthetic composition for reducing allergy symptoms
AU2018397320B2 (en) * 2017-12-29 2023-11-16 Societe Des Produits Nestle S.A. Serpin production
WO2019215302A1 (fr) * 2018-05-09 2019-11-14 Mjn U.S. Holdings Llc Complément de bien-être pour nutrition maternelle post-partum
US11166862B2 (en) 2018-12-06 2021-11-09 General Electric Company System and method for a thermoregulated environment
WO2021115990A1 (fr) * 2019-12-09 2021-06-17 Société des Produits Nestlé S.A. Compositions comprenant des oligosaccharides de lait humain destinées à être utilisées chez un sujet pour aider au développement du langage
CN115209745A (zh) * 2019-12-09 2022-10-18 雀巢产品有限公司 用于在个体中使用以支持语言发育的包含人乳低聚糖的组合物
WO2021116236A1 (fr) * 2019-12-11 2021-06-17 Mjn U.S. Holdings Llc Compositions nutritionnelles adaptées à diférents âges, comprenant des oligosaccharides de lait humain et leurs utilisations
WO2021136751A1 (fr) * 2019-12-30 2021-07-08 Société des Produits Nestlé S.A. Préparation pour nourrissons
WO2022055073A1 (fr) * 2020-09-14 2022-03-17 (주)에이피테크놀로지 Composition alimentaire pour soulager ou traiter une maladie cardio-cérébrovasculaire, et composition pharmaceutique pour prévenir ou traiter une maladie cardio-cérébrovasculaire, comprenant du 2'-fucosyllactose
KR102241938B1 (ko) * 2020-09-14 2021-04-20 (주)에이피테크놀로지 2'-푸코실락토오스를 포함하는 뇌심혈관 질환 개선용 식품 조성물
US11819510B2 (en) 2020-09-14 2023-11-21 Advanced Protein Technologies Corp. Food composition for ameliorating cerebrovascular diseases containing 2′- fucosyllactose and pharmaceutical composition for preventing or treating cerebrovascular diseases containing 2′-fucosyllactose
WO2022129518A1 (fr) * 2020-12-18 2022-06-23 Société des Produits Nestlé S.A. Compositions nutritionnelles synthétiques adaptées aux nourrissons chinois
WO2022253980A1 (fr) 2021-06-02 2022-12-08 N.V. Nutricia Nutrition du nourrisson, spécifique d'un stade de lactation

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RU2761533C2 (ru) 2021-12-09
US10820616B2 (en) 2020-11-03
RU2017113997A3 (fr) 2019-04-29
PH12017500174A1 (en) 2017-07-10
AU2015323762A1 (en) 2017-02-16
EP3197295A1 (fr) 2017-08-02
EP3197295B1 (fr) 2019-03-06
AU2020201932A1 (en) 2020-04-09
MX2017003441A (es) 2017-06-20
CN106714583A (zh) 2017-05-24
ES2725464T3 (es) 2019-09-24
US20170295838A1 (en) 2017-10-19
BR112017003920A2 (pt) 2017-12-12

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